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Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that FDA granted 510(k) clearance for the LithoVue TM Elite Ureteroscope on February 2, 2023

For example, a research report by Turquoise Health found that negotiated rates began converging between December 2021 and June 2024, and researchers from the University of Miami found that in Florida, patients seeking elective, self-paid care responded [to hospital price transparency] by choosing hospitals that were transparent about their prices, and hospitals, in turn, responded by simplifying their pricing and reducing the intensity of services. [449 450] Comment: Many commenters pointed out the need for more policy coordination across the various price transparency initiatives (HPT, TiC, NSA and state level efforts), and the importance of not addressing HPT policies in isolation